<font color="#000000" face="Times New Roman" size="3">

</font><p style="margin: 0in 0in 0pt;"><u><span style='font-family: "Times New Roman",serif;'><font color="#000000" size="3">INSTRUCTIONS
FOR RESPONSE </font></span></u></p><font color="#000000" face="Times New Roman" size="3">

</font><p style="margin: 0in 0in 0pt;"><span style='font-family: "Times New Roman",serif;'><font color="#000000" size="3">Please
respond to this letter by doing the following:</font></span></p><font color="#000000" face="Times New Roman" size="3">

</font><p style="margin: 0in 0in 0pt 0.5in; text-indent: -0.25in; mso-list: l0 level1 lfo1;"><span style='font-family: "Times New Roman",serif; mso-fareast-font-family: "Times New Roman";'><span style="mso-list: Ignore;"><font color="#000000"><font size="3">1.</font><span style='font: 7pt/normal "Times New Roman"; font-size-adjust: none; font-stretch: normal;'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></font></span></span><span style='font-family: "Times New Roman",serif;'><font size="3"><font color="#000000">The
Response to Review document is located on the forms tab.<span style="mso-spacerun: yes;">&nbsp; </span><b style="mso-bidi-font-weight: normal;">Please
provide your COMPLETE answer to the question in this form in a different font. </b></font></font><font color="#000000" size="3">Please
also state the page number and document</font><st1:citation w:st="on"><font color="#000000" size="3">(s)</font></st1:citation><font color="#000000" size="3">
which were changed in response to the question. The purpose of this "self
contained response document" is to make it easy for the reviewers to fully
understand your responses.</font><span style="mso-spacerun: yes;"><font color="#000000" size="3">&nbsp; </font></span><font color="#000000" size="3">Failing to
follow these directions is likely to slow down review of your project. This
format is </font><u><font color="#000000" size="3">not</font></u><font color="#000000" size="3"> required for consent form changes, where it is fine to
make the changes and submit the revised consent form with deletions in red
strike-through, and additions in yellow highlighting. </font></span></p><font color="#000000" face="Times New Roman" size="3">

</font><p style="margin: 0in 0in 0pt 0.5in; text-indent: -0.25in; mso-list: l0 level1 lfo1;"><span style='font-family: "Times New Roman",serif; mso-fareast-font-family: "Times New Roman";'><span style="mso-list: Ignore;"><font color="#000000"><font size="3">2.</font><span style='font: 7pt/normal "Times New Roman"; font-size-adjust: none; font-stretch: normal;'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></font></span></span><span style='font-family: "Times New Roman",serif;'><font color="#000000" size="3">Incorporate
into the Protocol Summary and any other relevant study documents the changes
outlined in this memo as well as any other changes made to address the
Committee's questions and concerns about the study. Please submit clean and
marked up copies of the revised document(s)</font><font color="#000000" size="3">.
</font><span style="mso-spacerun: yes;"><font color="#000000" size="3">&nbsp;</font></span><font color="#000000" size="3">This will facilitate the review of your
response.</font><span style="mso-spacerun: yes;"><font color="#000000" size="3">&nbsp; </font></span><font color="#000000" size="3">Revising documents ensures
that the study is conducted according to the updated Protocol and will
facilitate continuing review.</font></span></p><font color="#000000" face="Times New Roman" size="3">

</font><p style="margin: 0in 0in 10pt;"><font color="#000000" face="Calibri" size="3">&nbsp;</font></p><font color="#000000" face="Times New Roman" size="3">

</font>